Ellen Lipstein, MD, MPH is a primary care pediatrician whose overarching career goal is to improve outcomes for children with chronic conditions through fundamental changes in how families and care providers work to- gether to make difficult treatment decisions. The research she proposes here uses the decision to initiate treatment with tumor necrosis factor- inhibitors (TNFi) as a model of complex pediatric treatment decisions. This decision, which occurs in both inflammatory bowel disease (IBD) and juvenile idiopathic arthritis (JIA), is an ideal model of complex pediatric decisions due to significant trade-offs between disease and treatment risks, limited data regarding the ideal timing of treatment, and the opportunity to compare the decision in two different conditions. Candidate: Dr. Lipstein is an Assistant Professor of Pediatrics in the Center for Innovation in Chronic Disease Care within the Division of Adolescent Medicine at Cincinnati Children's Hospital Medical Center. She com- pleted a Master's in Public Health as part of her fellowship in pediatric health services research. Using that ini- tial training, she has conducted multiple studies focused on parents' preferences in pediatric health care and on health care utilization. The proposed K23 career development plan will build upon her fellowship training and early career development to focus on three areas that require additional training to enhance her trajectory toward becoming an independent investigator: 1) Medical decision making in pediatric chronic disease; 2) De- cision aid development and implementation; and 3) Advanced methodologic skills in qualitative, survey, and trials research. Dr. Lipstein proposes training activities that include coursework, seminars and experiential learning to enable her to gain the necessary skills for research and development of decision support interven- tions in pediatric chronic conditions. Mentors/Environment: Dr. Lipstein and her primary mentor, Maria Britto, MD, MPH, have assembled a strong team of co-mentors and advisors to guide Dr. Lipstein through the proposed training and research activities. The proposed career development plan utilizes the intellectual resources available through the University of Cincinnati and Cincinnati Children's Hospital, as well as nationally recognized seminars and courses when op- timal training is not available locally. As an institution Cincinnati Children's Hospital is committed to supporting junir faculty members through internal grants, administrative support and structured opportunities for faculty networking and education. Additionally, the divisions of gastroenterology and rheumatology, where Dr. Lip- stein's research will be conducted and from which her co-mentors are drawn, are each leaders in their respec- tive fields and provide key opportunities for understanding the context of decision making in pediatric chronic conditions. The two divisions also provide large patient populations allowing for the conduct of the proposed research. Research: Understanding the decision process and improving family decision making are key to goals of the Institute of Medicine, American Academy of Pediatrics and Healthy People 2020. However, to achieve these goals, pediatric decision-making research must move beyond retrospective and cross-sectional work and to- wards a detailed understanding of the decision-making process and theory-driven interventions. This proposal will begin to fill the gap, provide the needed prospective data and produce information and interventions that are readily applicable to clinical practice. Aim 1 will use innovative video observation and interviews to under- stand the current, longitudinal decision process for families making decisions about TNFi. Aim 2 will identify potentially modifiable barriers to and facilitators of high quality deciion making. Aim 3 will use the results of the prior aims to improve decision making about TNFi treatment by developing and pilot testing a decision sup- port intervention that addresses key modifiable aspects of decision making. The development of such decision support may improve the timeliness of decision making, thus leading to decreased delays in treatment and more rapid disease control. If parents are able to make high-quality decisions with less decisional regret, fami- lies will likely experience improved care, less parental stress associated with the decision and better family quality of life. Summary: The proposed innovative collaboration between general pediatrics, rheumatology and gastroenter- ology will allow for a full understanding of the decision context and maximize the clinical applicability and future implementation of decision support interventions. Dr. Lipstein's research and clinical training, pilot work inves- tigating ths decision and committed, experienced mentorship team make her ideally suited to pursue this line of research. This award will provide her with the training and research needed to be successful in a future, large-scale trial of decision support for families making decisions about TNFi treatment in IBD and JIA. Fur- thermore, this career development award will facilitate Dr. Lipstein's development into a nationally-recognized independent investigator and leader conducting research that improves the decision making process related to treatments for children with chronic conditions. PUBLIC HEALTH RELEVANCE: Family-centered, shared decision making, a priority of Healthy People 2020 and the Institute of Medicine, has the potential to improve outcomes for children with chronic conditions by ensuring they receive evidence-based treatment that also addresses their families' goals and values. This application aims to achieve such shared decision making by examining the current barriers to and facilitators of high-quality decision making and using that new knowledge to design a feasible, acceptable decision support intervention. While aimed at a decision about a specific treatment, the concepts learned through this grant, as well as the career development pursued by the investigator, will be readily applicable to challenging decisions in other pediatric chronic conditions.